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Table 2 Pharmacovigilance policy implementation situation in Jordan, Oman, and Kuwait. Adapted from Alshammari et al. [21]

From: A qualitative exploration of pharmacovigilance policy implementation in Jordan, Oman, and Kuwait using Matland’s ambiguity-conflict model

  Jordan Oman Kuwait
Organization overseeing pharmacovigilance Jordan Food and Drug Administration (JFDA) Oman Ministry of Health’s Directorate General of Pharmaceutical Affairs and Drug Control (DGPA&DC) Kuwait Ministry of Health’s Drug and Food Control Administration (KDFCA)
Pharmacovigilance system structure National & Regional Centres National Centre with Regional Centre Network National Centre (Unofficial)
Pharmacovigilance centre, department, or unit name Department of Rational Drug Use and Pharmacovigilance Department of Pharmacovigilance and Drug Information Drug Registration Department’s Quality Assurance Unit (Unofficial)
National pharmacovigilance system
establishment year
2001 1992 2008
Year joined WHO Program for International Drug Monitoring as full member 2001 1995 2021
Pharmacovigilance guidance or legislation Law titled “The Pharmacovigilance Directives” Guidelines titled “Guideline on Good Pharmacovigilance Practices in Oman” A memo issued by KDFCA to companies
Dedicated budget No No No
Number of staff members 5 full-time employees 5 full-time employees 5 full-time employees, plus one part-time employee
National adverse drug reaction (ADR) or pharmacovigilance advisory committee Health Hazard Evaluation Committee No No
Standard adverse drug reaction reporting form present Yes Yes Yes
Product types covered Pharmaceuticals, herbal medicines, cosmetics, biologicals, medical devices Pharmaceuticals, herbal medicines, biologicals Pharmaceuticals, herbal medicines, biologicals, medical devices
Type of drug-related
problems covered
Suspected ADRs, lack of efficacy, quality defects, drug abuse/misuse, medication errors Suspected ADRs, lack of efficacy, quality defects, medication errors, counterfeit Suspected ADRs, lack of efficacy, quality defects, medication errors, drug abuse/misuse, counterfeit
Computerized case-report management system Yes Yes No
Qualified Person for Pharmacovigilance (QPPV) Requirement Yes Yes No
Submission of regular
Periodic Safety Update Reports (PSUR)/Periodic Benefit-Risk Evaluation Reports (PBRER)
Originator and generic products Originator products only Originator and generic products
Submission of Risk
Management Plans (RMPs)
Yes Yes Yes